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Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
bone marrow aspiration /trephine biopsy
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  1. Patients over 18 years old and who have given informed consent to enter the study.
  2. ASA I-II patients
  3. Patients who have not been diagnosed as breast cancer or received any type of treatment regarding breast cancer before the time of study
  4. Patients who are appropriate for bone marrow biopsy
  5. Menopausal status is not relevant.

Exclusion criteria:

  1. Active collagen tissue disorders
  2. Patients who are diagnosed having breast cancer and received any type of treatment regarding breast cancer before the time of study
  3. Pregnancy
  4. Patients with bleeding disorders, who are receiving antiaggregant or anticoagulant medication.
  5. Patients who refused to enter the study protocol and refused to give informed consent.

Sites / Locations

  • Acibadem University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

all

Arm Description

All patients with early breast cancer

Outcomes

Primary Outcome Measures

Rate of bone marrow metastases in early stage breast cancer
Number of patients with bone marrow metastases/ total number of enrolled patients
Rate of sentinel lymph node metastases in early stage breast cancer
Rate of sentinel lymph node metastases in patients with bone marrow metastasis operated for early stage breast cancer
Incidence of bone marrow metastasis in HER-2 positive early stage breast cancer
Incidence of bone marrow metastases in triple negative early stage breast cancer

Secondary Outcome Measures

Incidence of axillary recurrence in patients with negative sentinel lymph node biopsy
Overall survival

Full Information

First Posted
May 17, 2016
Last Updated
September 29, 2016
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT02921152
Brief Title
Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer
Official Title
Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acibadem University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Operable early stage breast cancer patients staged according to NCCN guidelines are subjected to bone marrow aspiration/trephine biopsy at the time of the definitive operation under general anesthesia. The specimen will be fixated in neutral tamponaded formalin and the sections will be examined by H&E and cytokeratin immunohistochemically. If disseminated tumor cells are identified ER (estrogen receptor), PR (progesterone receptor), HER2/neu will be studied. Disseminated tumor cells will be recorded quantitively and semiquantitatively. Results of the pilot study will be evaluated as observational study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
all
Arm Type
Other
Arm Description
All patients with early breast cancer
Intervention Type
Procedure
Intervention Name(s)
bone marrow aspiration /trephine biopsy
Primary Outcome Measure Information:
Title
Rate of bone marrow metastases in early stage breast cancer
Description
Number of patients with bone marrow metastases/ total number of enrolled patients
Time Frame
up to 5 years
Title
Rate of sentinel lymph node metastases in early stage breast cancer
Time Frame
up to 5 years
Title
Rate of sentinel lymph node metastases in patients with bone marrow metastasis operated for early stage breast cancer
Time Frame
up to 5 years
Title
Incidence of bone marrow metastasis in HER-2 positive early stage breast cancer
Time Frame
up to 5 years
Title
Incidence of bone marrow metastases in triple negative early stage breast cancer
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
Incidence of axillary recurrence in patients with negative sentinel lymph node biopsy
Time Frame
Up to 10 years
Title
Overall survival
Time Frame
up to 10 years
Other Pre-specified Outcome Measures:
Title
Disease free survival
Time Frame
up to 10 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients over 18 years old and who have given informed consent to enter the study. ASA I-II patients Patients who have not been diagnosed as breast cancer or received any type of treatment regarding breast cancer before the time of study Patients who are appropriate for bone marrow biopsy Menopausal status is not relevant. Exclusion criteria: Active collagen tissue disorders Patients who are diagnosed having breast cancer and received any type of treatment regarding breast cancer before the time of study Pregnancy Patients with bleeding disorders, who are receiving antiaggregant or anticoagulant medication. Patients who refused to enter the study protocol and refused to give informed consent.
Facility Information:
Facility Name
Acibadem University School of Medicine
City
Istanbul
ZIP/Postal Code
34515
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deniz Boler, Ass Prof
Phone
5326458259
Email
denniseren@yahoo.com
First Name & Middle Initial & Last Name & Degree
Cihan Uras, Prof

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer

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